NCT03312595

Clinical Outcomes After Treatment With RestrataTM Wound Matrix in Diabetic Foot Ulcers (DFU)

Clinical Outcomes After Treatment With RestrataTM Wound Matrix in Diabetic Foot Ulcers (DFU) A Case Series of Initial Effectiveness and Safety Measures

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Acera Surgical, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

The primary objective of this study is to determine the outcomes of patients who receive a certain type of skin substitute called RestrataTM Wound Matrix (Restrata™). Results of this study may be used to make decisions on whether to conduct additional studies on this particular wound matrix product. RestrataTM has been cleared by the Food and Drug Administration for use in certain types of ulcer treatments, including the type that will be part of this study (diabetic foot ulcers).

Detailed description

Control Group: None (Utilize historical / published data on outcomes using standard of care) Test Group: Treatment of DFUs with RestrataTM Wound Matrix Study Type: Interventional Study Design: Allocation: Non-randomized Endpoint Classification: Efficacy Intervention Model: Direct assignment Masking: Single Blind (Subject) Primary Purpose: Treatment

Conditions

• Diabetic Foot Ulcer

Interventions

Type	Name	Description
DEVICE	Restrata TM Wound Matrix	The RestrataTM Wound Matrix is a sterile, single use device intended for use in local management of wounds

Timeline

• Start date: 2017-09-14
• Primary completion: 2018-07-15
• Completion: 2018-07-30
• First posted: 2017-10-18
• Last updated: 2025-09-16
• Results posted: 2021-04-26

Locations

5 sites across 1 country: United States

Regulatory

• FDA-regulated device study